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Chemoradiotherapy Sequenced Radical Surgery for Colorectal Cancer With PALNM

S

Shandong University

Status

Not yet enrolling

Conditions

Colorectal Neoplasms Malignant
Lymph Node Excision
Chemoradiotherapy

Treatments

Procedure: Radical surgery with PALND
Procedure: Radical surgery without PALND

Study type

Interventional

Funder types

Other

Identifiers

NCT05129774
V123456

Details and patient eligibility

About

In left-sided colon and rectal cancer, the occurrence of synchronous para-aortic lymph node metastasis is rare, with the incidence of being approximate 1-2%. Currently, there has been no standard treatment strategy for this situation. The present trial is designed to evaluate the safety and efficacy of para-aortic lymph node dissection for left-sided colon and rectal cancer with synchronous para-aortic lymph node metastasis

Enrollment

40 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • age at enrollment is ≥ 18 and ≤ 75 years
  • ECOG PS 0-1
  • histologically confirmed left-sided colon and rectal carcinoma
  • synchronous para-aortic lymph node metastases confirmed by PET-CT, and located below the level of renal veins and above the bifurcation of iliac artery
  • patients potential to receive surgery and achieve no evidence of disease (NED)
  • able to tolerate surgery
  • providing written informed consent

Exclusion criteria

  • local invasion or distant metastasis other than para-aoritc lymph nodes
  • history of other malignant tumor
  • coupled with severe systematic diseases (recent myocardial infarction, cardiomyopathy, or acute pulmonary infection)
  • emergency surgery

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Triple Blind

40 participants in 2 patient groups

radical surgery with PALND
Experimental group
Treatment:
Procedure: Radical surgery with PALND
radical surgery without PALND
Active Comparator group
Treatment:
Procedure: Radical surgery without PALND

Trial contacts and locations

1

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Central trial contact

Yong Dai, M.D. Ph.D.; Xiang Zhang, M.D. Ph.D.

Data sourced from clinicaltrials.gov

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